A Multicenter Trial to Evaluate the Efficacy and Safety of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Phase 3
- Registration Number
- CTRI/2009/091/000121
- Lead Sponsor
- The pharmaceutical company sponsoring this study is Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 435
Inclusion Criteria
1. ≥ 18 and ≤ 78 years old
2. Type 2 diabetes
3. Taking stable dose of basal or pre-mixed insulin for at least 8 wks
4. If taking metformin, dose must be stable for ≥ 2 months
5. A1C ≥ 7.5% and ≤ 11.0%
6. BMI ≤ 45 kg/m²
7. Fasting C-peptide ≥ 0.8 ng/m
Exclusion Criteria
1. WOCBP unable or unwilling to use acceptable birth control
2. Women who are pregnant or breastfeeding
3. Significant cardiovascular history in last 6 months
4. Active liver disease
5. Renal impairment
6. Anemia
7. Only using short-acting or rapid-acting insulin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method